1. Field of the Invention
The present invention pertains to a rapid economical fail-safe method to routinely detect retained surgical materials, i.e, surgical instruments, sponges, implantable devices, indwelling therapuetic devices or materials.
2. Historical Background
Despite elaborate precautions several times each year, patients who have undergone surgical operations have had surgical implements left in their bodies. These unfortunate incidents adversely affect the patient, the medical profession, involved doctors, hospitals, and involved insurance companies. Headlines announcing six and seven digit law suits and settlements are brought to the attention of the public with alarming frequency. There is a definite need for a system to routinely screen and detect retained surgical materials in the bodies of human patients while still under anesthesia and on the operating room table prior to the surgical wound closure.
3. Description of the Prior Art
Currently, intraoperative visual inspection is the only routine method for detection of misplaced or retained surgical implements. X-ray examination is the only means of detection of such materials once the patient's body is closed. Surgical instruments being metal, are opaque to X-rays and easily seen in roentgengram. Sponges and ancillary materials are made radiopaque to X-rays by incorporation of radiopaque threads, e.g., barium impregnated latex.
While this method of surgical material detection is reliable, it suffers from numerous drawbacks and is not routinely used before closing the patient. To accomplish routine screening of all operative patients would be very costly in terms of equipment, operating room time, professional time, radiation safety enforcement and would entail additional X-radiation exposure to patients. To be done in the operating room prior to closing the patient's body would lengthen the operative procedure, inefficiently use the operating room and surgeon's professional time, and inevitably increase the cost of medical care.
The X-ray examination could be carried out in an area outside the operating room, e.g., the recovery room, but this becomes an "after-the-fact" detection, requiring the patient to be returned to the operating room, re-anesthetized, and re-opened for removal of the detected material with concurrent increased health and medical-legal risks entailed in a second procedure. Relocation of the procedure to an area outside the operating room would retain numerous financial and personnel drawbacks.
Yet another approach, not currently used, would be the use of radionucleides (isotopes) as tracers for detecting surgical implements with subsequent screening of the patients using scintillation counting equipment, survey meters or similar devices. Serious drawbacks to this concept are: accumulation of isotopically labeled material in the hospital would introduce burdensome regulation relative to isotopes; the increased background radioactivity of the operating room and hospital would cause increasing difficulty in the detection system itself and perhaps interfere with radioisotope assays in other areas of the hospital; the creation of a possible chronic radiation hazard to the operative personnel; the necessity for establishing and implementing radiation safety procedures. Lastly, the drawback relating to increased radiation exposure to patients and the possibility of long term radiation exposure to the patients if undetected radioactive materials were left in their bodies.